Otto Bock 3F1-1, Instructions For Use Manual

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damage caused by disregarding the information in this document, particularly due to improper
use or unauthorised modification of the product.
8.2 CE conformity
This product meets the requirements of the European Directive 93/42/EEC for medical devices.
This product has been classified as a class I device according to the classification criteria out­
lined in Annex IX of the directive. The declaration of conformity was therefore created by the man­
ufacturer with sole responsibility according to Annex VII of the directive.
8.3 Trademarks
All product names mentioned in this document are subject without restriction to the respective
applicable trademark laws and are the property of the respective owners.
All brands, trade names or company names may be registered trademarks and are the property of
the respective owners.
Should trademarks used in this document fail to be explicitly identified as such, this does not justi­
fy the conclusion that the denotation in question is free of third-party rights.
9 Technical data
Environmental conditions
Storage and transport in original packaging -25 °C/-13 °F to +70 °C/+158 °F
Storage and transport without packaging -25 °C/-13 °F to +70 °C/+158 °F
Max. 93% relative humidity, non-condensing
Operation -10 °C/+14 °F to +60 °C/+140 °F
15% to 93% relative humidity, non-condensing
General information
Reference number 3F1=1 / 3F1=2
Service life of the functional cosmesis 2 years
The service life diminishes or increases
depending on the individual level of use. Only
when the instructions for use are observed it is
possible to achieve the maximum service life, in
dependence of the level of use.
Service life of the functional stocking 6 months
Wear part, subject to natural wear and tear.
The service life diminishes or increases
depending on the individual level of use. Only
when the instructions for use are observed it is
possible to achieve the maximum service life, in
dependence of the level of use.
Weight of the functional cosmesis (without
adaptations) 910 g
10 Appendix
10.1 Symbols Used
Manufacturer